Phase 3
Completed N=466
A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01582451 ↗Enrolled (actual)
466
Serious AEs
12.5%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c) — -0.82; -0.29 percentage of HbA1c
◆ Published Evidence
Highly cited
185citations · ~21 / year
Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes.
Summary
The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:
* Change in participants' overall blood sugar control
* The rate of night time low blood sugar episodes
* The number of participants that reach blood sugar targets without low blood sugar episodes at night
* The rate of low blood sugar episodes reported over a 24-hour period
Linked Publications (5)
-
Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes.
-
Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5.
-
Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
-
Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins.
-
The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c) |
-0.82; -0.29 | — |
| SECONDARY Change From Baseline to 52 Weeks in HbA1c |
-0.67; -0.22 | — |
| SECONDARY Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days) |
1.55; 1.98; 1.24; 1.62; 0.43; 1.04 | — |
| SECONDARY Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events |
76.3; 80.5; 80.3; 83.0; 46.1; 62.3 | — |
| SECONDARY Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0% |
50.3; 28.7; 43.4; 28.0; 72.5; 52.2 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia |
40.1; 18.5; 34.8; 10.2 | — |
| SECONDARY Fasting Serum Glucose (FSG) (by Laboratory) |
103.80; 119.50; 107.61; 115.74 | — |
| SECONDARY Fasting Blood Glucose (FBG) (by Self Monitoring) |
106.32; 104.50; 110.61; 107.46 | — |
| SECONDARY Intra-participant Variability in Fasting Blood Glucose (FBG) |
13.70; 17.90; 14.18; 17.38 | — |
| SECONDARY 6-point Self-monitored Blood Glucose (SMBG) |
107.93; 104.11; 120.87; 132.56; 125.87; 141.45 | — |
| SECONDARY HbA1c |
6.60; 7.13; 6.75; 7.20 | — |
| SECONDARY Insulin Dose Per Kilogram of Body Weight |
0.57; 0.49; 0.58; 0.49 | — |
| SECONDARY Number of Insulin Dose Adjustments to Steady-state |
4.06; 2.75 | — |
| SECONDARY European Quality of Life - 5 Dimension (EuroQol-5D) Score |
0.87; 0.88 | — |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) Score |
85.69; 84.43 | — |
| SECONDARY Adult Low Blood Sugar Survey (LBSS) Score |
16.57; 15.63 | — |
| SECONDARY Change From Baseline in Body Weight |
0.50; 0.94; 0.69; 1.32 | — |
| SECONDARY Change From Baseline in Lipid Profile |
2.24; 3.70; -1.35; 2.78; -1.74; -0.06 | — |
| SECONDARY Number of Participants With Change in Anti-LY2605541 Antibodies |
70; 30 | — |
Eligibility Criteria
Inclusion Criteria
- Have had type 2 diabetes mellitus for at least 1 year
- Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
- Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Exclusion Criteria
- Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
- Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia within 6 months prior to screening
- Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
- Have cardiac disease with functional status that is New York Heart Association Class III or IV
- Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L])
- Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L]) at screening
- Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
- Lipid-lowering medication: Are using or have used any of the following:
- niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
- lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
Data sourced from ClinicalTrials.gov (NCT01582451) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.